Experimental Baldness Treatment Shows Major Hair-Regrowth Gains in Late-Stage Trials

A topical treatment used previously for acne has shown strong results in reducing male-pattern hair loss, also known as androgenetic alopecia (AGA).

Experts say the findings for clascoterone are promising, potentially marking the first new approach to reversing hair loss in decades.

Cosmo Pharmaceuticals conducted two large, late-stage trials in Ireland, named Scalp 1 and Scalp 2, which enrolled a combined 1,465 men across the U.S. and Europe.

Participants applied either the clascoterone solution or a placebo under randomized conditions. The primary measure of success was the “target-area hair count” (TAHC), which counts hairs in a defined area of the scalp.

Clascoterone works by blocking the action of dihydrotestosterone (DHT) directly at hair follicle receptors, rather than affecting hormones system-wide, according to Cosmo Pharmaceuticals. This localized approach targets the biological root cause of AGA without exposing the entire body to additional hormones.

In Scalp 1, participants using clascoterone showed a 539% relative improvement in hair count compared with the placebo group. Scalp 2 participants showed a 168% relative improvement.

Maria Hordinsky, M.D., from the University of Minnesota’s Department of Dermatology, told Fox News: “For decades, patients have had to choose between available treatment options with limited efficacy or safety issues due to systemic hormonal exposure, often resulting in patients not treating their hair loss at all. These findings show the potential for clascoterone 5% topical solution to change that equation by delivering real, measurable regrowth with negligible systemic exposure.”

Patient-reported outcomes were also positive. When data from both trials were combined, improvements were described as statistically significant and aligned with the counted-hair results.

Marc Siegel, M.D., senior medical analyst for Fox News, commented: “We really don’t have a very effective cream or lotion for hair loss, so this may be valuable for widespread clinical use.”

Side effects in the trials were minimal and similar to the placebo group, with the most common issue being local irritation. Researchers reported no unexpected adverse effects.

Siegel cautioned that allergic reactions or rare cases of adrenal insufficiency could occur because clascoterone blocks androgens, which may slightly affect adrenal gland function.

Cosmo Pharmaceuticals plans to complete a full 12-month safety follow-up by spring 2026 before seeking regulatory approval in the U.S. and Europe. If approved, clascoterone would be the first treatment specifically designed to block DHT directly at the hair follicle for male-pattern baldness.

Full data, including long-term results and detailed hair-count changes, are still pending regulatory review. Individual results may vary depending on baseline hair levels.